Phase 3 N=728 Treatment

Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT05142774 ↗

Enrolled (actual)

728

Serious AEs

4.7%

Results posted

Aug 2025

Primary outcome: Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events — 451; 34 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tapinarof cream, 1% (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events	451; 34	—
PRIMARY Frequency of Adverse Events and Serious Adverse Events	1226; 45	—
PRIMARY Change From Baseline in Clinical Laboratory Values (g/L)	-0.5; 0.0; 1.7; 0.0	—
PRIMARY Change From Baseline in Clinical Laboratory Values (U/L)	-14.9; -1.5; -2.6	—
PRIMARY Change From Baseline in Clinical Laboratory Values (mmol/L)	-0.2; 0.04; -0.019; -0.3; 0.13; -0.03	—
PRIMARY Change From Baseline in Clinical Laboratory Values (Umol/L)	0.40; 2.1; 2.7; 0.9	—
PRIMARY Change From Baseline in Clinical Laboratory Values (10^9 Cells/L)	0.01; -.03; -0.02; 0.00; 0.22; -4.0	—
PRIMARY Change From Baseline in Clinical Laboratory Values (%)	0.03; -0.39; -0.73; -0.09; 1.18; -0.06	—
PRIMARY Change From Baseline in Clinical Laboratory Values (L/L)	0.005	—
PRIMARY Change From Baseline in Clinical Laboratory Values (pg)	0.13	—
PRIMARY Change From Baseline in Clinical Laboratory Values (fl)	0.37	—
PRIMARY Change From Baseline in Clinical Laboratory Values (10^12 Cells/L)	0.038	—
PRIMARY Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance vIGA-AD =0 (Clear) While on Therapy for Subjects Entered LTE vIGA-AD ≥ 1 (Almost Clear )	320	—
PRIMARY Response During LTE: Number of Subjects Achieving vIGA-AD =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With vIGA-AD ≥ 2 (Mild)	347	—
PRIMARY Absolute Change From Baseline in %BSA Affected	-7.14	—
PRIMARY Percent Change From Baseline in %BSA Affected	-37.45	—
PRIMARY Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score	-4.19	—
PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score	-33.70	—
PRIMARY Percent of Subjects With ≥ 50% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.	325	—
PRIMARY Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.	256	—
PRIMARY Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.	178	—
PRIMARY Mean Change in Peak Pruritis-Numeric Rating Scale (PP-NRS) From Baseline	-1.618	—
PRIMARY Number of Subjects With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the PP-NRS From Baseline	94	—
PRIMARY Change From Baseline in Vital Signs - Pulse	-0.9	—
PRIMARY Change From Baseline in Vital Signs - Blood Pressure (Systolic and Diastolic)	1.0; 0.7	—
PRIMARY Change From Baseline in Vital Signs - Temperature	0.02	—

Summary

This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.

Eligibility Criteria

Inclusion Criteria

For Roll-over Subjects Only:

Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study).
Must not be pregnant at Baseline

For Direct-Enrolling Subjects Only:

Male and female subjects ages 2 years to 1.5x ULN
Current or chronic history of liver disease
Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
Subjects who would not be considered suitable for topical therapy
Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
Pregnant or lactating females
History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05142774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.